Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors

Phase 1

Completed

• Conditions: Malignant Disease
• Interventions: Drug: MP-470 + paclitaxel/carboplatin; Drug: MP-470 + carboplatin/etoposide; Drug: MP-470 + topotecan; Drug: MP-470 + docetaxel; Drug: MP-470 + erlotinib

• Registration Number: NCT00881166
• Lead Sponsor: Astex Pharmaceuticals, Inc.

Brief Summary

Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing regimen will be enrolled in each treatment arm.

Primary objective: Determine the MTD.

Secondary objectives: Response rates, PK, quantify MP-470 on PK of SOC, and collect pharmacodynamic information. Evaluate the overall safety of MP-470 when co-administered with specific SOC treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-04-13
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Malignant disease appropriate for initiating treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel, or erlotinib.
2. Must be able to read, understand, and sign the IRB approved Informed Consent Form.
3. At least 18 years old.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Adequate bone marrow function; normal renal and hepatic function, normal cardiac function.

Exclusion Criteria

1. Any other active invasive malignancy except non-melanoma skin cancers or cervical carcinoma in situ.
2. History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure and/or myocardial infarction.
3. Received any anticancer agent(s) within the past 3 weeks, including investigational agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic or hormonal therapy other than LHRH agonists.
4. Received prior radiation therapy within the past 4 weeks.
5. Any serious, uncontrolled active infection that requires systemic treatment or known infection with HIV, HCV or HBV.
6. Patient requires treatment with immunosuppressive agents other than corticosteroids appropriate for the SOC chemotherapy regimen or those at stable doses for at least 2 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MP-470 + paclitaxel/carboplatin	oral MP-470 + paclitaxel/carboplatin
2	MP-470 + carboplatin/etoposide	oral MP-470 + carboplatin/etoposide
3	MP-470 + topotecan	oral MP-470 + topotecan
4	MP-470 + docetaxel	oral MP-470 + docetaxel
5	MP-470 + erlotinib	oral MP-470 + Erlotinib

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	March 2010

Secondary Outcome Measures

Name	Time	Method
Response rate	March 2010
Experience DLT	March 2010
Pharmacokinetics, pharmacodynamic effects on biomarker modulation.	March 2010

Trial Locations

Locations (4)

Premiere Oncology; 🇺🇸 Santa Monica, California, United States

Audie Murphy Veterans Memorial Hospital (VA); 🇺🇸 San Antonio, Texas, United States

CTRC at the UT Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

South Texas Accelerated Research Therapy (START); 🇺🇸 San Antonio, Texas, United States